Multicenter clinical trial, phase III, controlled by active medicine, open, randomized, enroll 962 children, 2 to 12 years old, that suffer acute inflammation upper airway characterized by non-productive cough, daytime/nighttime, with duration for at least 3 and no more than 5 consecutive days (without systemic/topic use of medication during this period) followed by nasal congestion, with or without associate other nasal symptoms (sneezing, runny nose, nasal itching and/or mouth breathing). The subjects will be allocated in 2 parallel groups, and will receive the medicines of study, according of the randomization.

Multicenter Clinical Trial, Phase III, Controlled, Open, Parallel Group, Randomized, Comparing the Fixed Dose Combination of Diphenhydramine + Dropropizine + Pseudoephedrine and the Combined Use of Dropropizine and Fixed Dose Combination of Pseudoephedrine Hydrochloride + Brompheniramine Maleate Used Orally for Evaluation of Efficacy and Safety in Control Cough and the Relief of Nasal Symptoms in Children 2 to 12 Years Old, Suffering From Non-productive Cough and Acute Rhinitis.

Further study details as provided by Ache Laboratorios Farmaceuticos S.A.:

Primary Outcome Measures:

Improvement of nasal congestion and cough [ Time Frame: Evaluated on the day 2 after beginning treatment ] [ Designated as safety issue: No ]

Participants were evaluated (by a parent/guardian/caregivers) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe.

Secondary Outcome Measures:

Improvement of nasal congestion and cough [ Time Frame: Evaluated on the 7(±1) day after beginning treatment ] [ Designated as safety issue: No ]

Participants were evaluated (by a parent/guardian/caregivers) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe.

Improvement of non-obstructive nasal symptoms [ Time Frame: Evaluated on the day 2 and 7 (±1) after beginning treatment ] [ Designated as safety issue: No ]

Participants were evaluated (by a parent/guardian/caregivers for pain intensity by using a sum of 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe.

Reduction of the frequency of nighttime awakenings of parent/guardian/roommate of the child [ Time Frame: Evaluated on the day 2 and 7 (±1) after beginning treatment ] [ Designated as safety issue: No ]

Reduction of vomiting frequency episodes triggered by coughing [ Time Frame: Evaluated on the day 2 and 7 (±1) after beginning treatment ] [ Designated as safety issue: No ]

Improvement of acute rhinitis signs [ Time Frame: Evaluated on the day 2 and 7 (±1) after beginning treatment ] [ Designated as safety issue: No ]

Assessed by anterior rhinoscopy and application of specific clinical scores

Use of rescue medication [ Time Frame: Evaluated on the day 2 and 7 (±1) after beginning treatment ] [ Designated as safety issue: No ]

Overall impression of improvement by the investigator [ Time Frame: Evaluated on the day 2 and 7 (±1) after beginning treatment ] [ Designated as safety issue: No ]

Specific scale and overall impression of improvement by a parent/guardian/ caregiver of the child

Safety descriptive about occurence of adverse events, evaluation of results of general physical examination. [ Time Frame: Will be evaluated during the 7(± 1) days of treatment ] [ Designated as safety issue: Yes ]

Non-productive cough, daytime and/or nighttime with at least 3 and up 5 consecutive days in duration;

Score greater than or equal to 3 points on the cough severity score (As per item 4.1.2);

Score greater than or equal to 2 points on the nasal obstruction severity score (As per item 4.1.3);

ICF signed by a parent/caregiver/representant;

Parent/Caregiver/Representant capacity, according to investigator evaluation, for compliance at the treatment and protocol requirements, fulfilling the regular visits;

Exclusion Criteria:

Non-productive cough with purulent smear, fever (axillar temperature superior than 37,8°C/100°F), purulent runny nose and other signs and symptoms of bacteria infection of upper and lower airways at 7 days before the screening/randomization visit;

Patient or parent/caregiver/representant with a history of lack of compliance to treatment or previous treatment protocols;

Any finding of clinical observation (anamnesis and physical exam) laboratory abnormality (eg, blood glucose, blood count), disease (for example, liver, cardiovascular system, lung) or therapy that, in opinion of the investigator, may endanger the patient or interfere with the endpoints of study.

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